Tris Pharma Inc. recalls Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bit
Recalled July 31, 2019 · FDA recall D-1517-2019 · Tris Pharma
Hazard
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. · FDA Class II
Units
2,550 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Product
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.
Manufacturer(s)
Tris Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →